1. Finnish Safety and Chemicals Agency (Tukes) Communication of Serious Undesirable Effects, Information on Substances Jarkko Loikkanen, Senior Officer TAIEX Workshop on the Introduction of EU Legislation on Cosmetic Products 22-23 February 2016, Belgrad (Serbia)

2. Finnish Safety and Chemicals Agency Topics Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)  SERIOUS UNDESIRABLE EFFECTS  Definitions  Criteria  OBLIGATIONS  Responsible person  Distributor  Authority  NOTIFICATION AND TOOLS  SUE forms (A, B and C)  ICSMS  CAUSALITY ASSESSMENT

3. Finnish Safety and Chemicals Agency Safety requirement Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)  One of the main objectives of EU’s Cosmetics Regulation: ”High level of protection of human health”  Some consumers may experience undesirable effects  Most common undesirable effects related to use of cosmetic products:  Local irritation  Allergic reactions  Some effects may also be serious in nature

4. Finnish Safety and Chemicals Agency Definitions (article 2) Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia) Undesirable effect: Means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product Serious undesirable effect (SUE): Means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death

5. Finnish Safety and Chemicals Agency Temporary or permanent functional incapacity Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)  Temporary or permanent physical damage  affecting the quality of life and/or  making difficult to exercise usual occupation and/or activities  Examples:  A work stoppage or sick leave ( e.g. hairdresser with an allergy to hair colouring products)  An event requiring medical observation in an emergency room without an hospitalization thereafter ( e.g. facial oedema, respiratory problems );  Significant changes in physical appearance ( e.g. allergy reactions on face and body, hair loss, burns... ).  Temporary loss of primary sense ( e.g. vision or taste )

6. Finnish Safety and Chemicals Agency Disability Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)  Long-term impairment (e.g. physical, mental, intellectual, sensory) which in interaction with various barriers may hinder full and effective participation in society on an equal basis with others  Disability should be established medically

7. Finnish Safety and Chemicals Agency Hospitalization Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)  Admission to the hospital whatever the delay between the cosmetic use and the hospitalization if a causal relationship is suspected  Not considered as hospitalization (without admission):  A treatment in an emergency room  Consultation in a hospital

8. Finnish Safety and Chemicals Agency Congenital anomaly Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)  A congenital anomaly in a child which may have resulted form an exposure of:  either mother or father to a cosmetic product prior to conception  Mother during pregnancy  This should refer to a physiological or structural anomaly still present at the birth  This excludes hereditary diseases

9. Finnish Safety and Chemicals Agency Immediate vital risk Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)  Event  In which the subject was at risk of death at the time of the event  Whose natural evolution without medical treatment might have have resulted in the death of the patient within 24 h  Examples:  Allergic bronchospasm  Anaphylactic shock Vital risk does not refer to an event/reaction which hypothetically might have caused death if it was more severe Death o Death after the cosmetic use if a causal relationship is suspected whatever the delay

10. Finnish Safety and Chemicals Agency Communication of serious undesirable effects (SUE) Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)  EU’s Cosmetics Regulation (No 1223/2009): Article 23  Responsible person and distributors  Obligation to notify all SUE cases to the CA of the MS where SUE occured  Without delay ( 20 calendar days )  Standardised SUE reporting form  Initial report  Follow-up report ( if relevant new information obtained)  End users and health professionals  No obligation to notify  Recommendation to notify responsible person or distributor  Can also directly notify the CA of the MS where SUE occured  Only SUE cases to authorities (not UEs)  Responsible person and distributor should ensure that the case in question fulfils the seriousness criteria

11. Finnish Safety and Chemicals Agency The role of the CA in communication of SUE Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)  Upon receiving SUE notifications  Check the information provided (e.g. are seriousness criteria fulfilled)  Causality assessment  Transmit the information immediately (20 calendar days) 1)to the CAs of the other Member States and also 2)to responsible person, if original notification from distributor, end user or health professional  ICSMS  The internet-supported information and communication system for the pan- European market surveillace  https://webgate.ec.europa.eu/icsms/ https://webgate.ec.europa.eu/icsms/

12. Finnish Safety and Chemicals Agency SUE forms, instructions and guidelines Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia) 1)SUE A Form  Responsible person and distributor  Available in all the official EU languages  Instructions on Form A available only in English  Include all available information on the case  Suspected cosmetic product (Full name, CPNP number etc) 2)SUE B Form  Used by authorities  Original notification from responsible person or distributor (SUE A ) 3)SUE C Form  Use by authorities  Original notification from end user or health professional European Commission: http://ec.europa.eu/growth/sectors/cosmetics/market-surveillance/index_en.htm http://ec.europa.eu/growth/sectors/cosmetics/market-surveillance/index_en.htm  SUE reporting guidelines + causality assessment  SUE forms and instructions on forms  National contact points in charge of SUE

13. Finnish Safety and Chemicals Agency SUE notifications Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)  Standardised forms to be used  Minimun information for the initial notification 1.An identifiable reporter 2.The nature of the alleged SUE and the date of its onset 3.The name of the cosmetic product concerned enabling its specific identification (CPNP number)  Identification and traceability of SUEs  Company and CA case identification numbers  Data privacy protection and confidentiality issues  Confidentiality of the information  End users and/or notifiers (e.g. health professional) should not be identified by their name and address

14. Finnish Safety and Chemicals Agency SUE notification: Responsible person or distributor Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia) National CA CAs of the other Member states Distributor Responsible person End users Health professionals End users Health professionals SUE A + B SUE A SUE A + B

15. Finnish Safety and Chemicals Agency SUE notification: End user or health professional Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia) National CA CAs of the other Member states Responsible person End user SUE C Health professional SUE C

16. Finnish Safety and Chemicals Agency Causality assessment Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)  Annex 1 to SUE reporting guidelines  The aim of the causality assessment is to assess cause- and-effect relationship between cosmetic products and given clinical and/or paraclinical effects  Should be included in SUE notification by responsible person and also by distributor (if possible)  Assessment includes Chronological score: time sequence between use of the cosmetic product and occurence of the symptoms Semiological score: nature of the effect + the results of any specific additional examination (AE) or of re-exposure (RE)

17. Finnish Safety and Chemicals Agency Additional examinations and re-exposure Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)  Results of additional examinations (AE) rated AE (+): positive AE (-): negative AE (?): if no examinations were performed or if the results were ambiguous  Criteria for AE  Must be reliable  Specific to the observed effect  Performed by specialist physicians  Outcome of re-exposure (R) to the cosmetic product R (+): positive; initial symptomatology recurs with the same intensity or with a higher intensity R (?): no re-exposure to the product or the conditions of re-exposure are not identical to those of the initial exposure R (-): negative; the effect does not recur when the user is re-exposed to the product

18. Finnish Safety and Chemicals Agency Causality assessment Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)  The chronological and semiological scores are combined  Decision table or  Decision tree  5 levels of causality  Very Likely  Likely  No clearly attributable  Unlikely  Excluded

19. Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia) Symptoms Time sequence between exposure and occurrence of the symptoms EVOCATIVE of use of the cosmetic product ONLY PARTIALLY OR NOT EVOCATIVE of use of the cosmetic product R and/or AE + R and/or AE ? R and/or AE - R and/or AE + R and/or AE ? R and/or AE - Compatible Very likely Likely Not clearly attributable Likely Not clearly attributable Unlikely Only partially compatible or unknown Likely Not clearly attributable Unlikely Not clearly attributable Unlikely Unlikely Incompatible Excluded Excluded Excluded Excluded Excluded

20. Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia) Symptoms Chronology Only partially compatible or unknown AE and/or RE Negative AE and/or RE Not performed or equivocal results AE and/or RE Positive AE and/or RE Positive AE and/or RE Negative AE and/or RE Not performed or equivocal results Likely Not clearly attributable Very likelyLikely Not clearly attributable Unlikely Chronology Compatible Symptoms: If the symptoms are not evocative (not suggestive of the product effect), the final level of causal relationship is decreased by one degree Compatible chronology: A time sequence between product use and the occurence of symptoms as well as between stopping product use and clearing up of the symptoms which is plausible. If not compatible → excluded

21. Finnish Safety and Chemicals Agency Subsequent actions Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)  Responsible person  Analysis of the data  Inclusion in the cosmetic product safety report  Information to the public  Corrective action  Competent authorities  Evaluation of trend or signal detection  End user information

22. Finnish Safety and Chemicals Agency Information on substances (Article 24)  Serious doubt regarding the safety of a substance  CA by reasoned request may require responsible person to  submit a list of all cosmetic products under his responsibility and which contains this substance  Indicate the concentration of this substance in products  CAs may use the information referred to in Article 24 for the purposes of  In-market surveillance  Market analysis  Evaluation  Consumer information in context with:  Article 25 (Non-compliance by the responsible person)  Article 26 (Non-compliance by distributors)  Article 27 (Safeguard clause) Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)

23. Finnish Safety and Chemicals Agency Thank you! jarkko.loikkanen@tukes.fi jarkko.loikkanen@tukes.fi